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van CCT (UK)

van CCT (UK)

Lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab

- candidate number29714
- NTR NumberNTR7585
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-okt-2018
- Secondary IDsNL67752.078.18 METC
- Public TitleLipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab
- Scientific TitleDeep profiling of lipid changes in patients with active ulcerative colitis treated with either tofacitinib or infliximab
- hypothesisTreatment with tofacitinib or infliximab show similar changes in lipid and lipoprotein levels in patients with ulcerative colitis
- Healt Condition(s) or Problem(s) studiedInfliximab , Ulcerative colitis, Lipids, Tofacitinib
- Inclusion criteria- aged 18 years or older
- previous diagnosis with ulcerative colitis (UC) of at least 3 months
- at least moderately active UC defined as SCCAI-score 5 or FCP >150 ug/g
- 5-ASA or thiopurine refractory or intolerant disease
- BMI 20-35 kg/m2
- Exclusion criteria- absence written informed consent
- imminent need for in-hospital treatment
- concomitant use of oral of intravenous corticosteroids (except locally administered budesonide down tapering)
- current or previous treatment with a biological agents (except history of infliximab use with good clinical response, discontinued at least 12 weeks prior to randomization)
- concomitant use of lipid-regulating agents, ormonal forms of contraception, isotretinoin, supplements with plant sterols, stanols or cholestin
- current or previous treatment with investigational drugs
- pregnancy or lactation
- concomitant disease or abnormalities (pancytopenia, kidney or liver failure, acute/latent/inadequately treated infection, hyperlipidemia, hypoalbuminemia, cardiopulmonary disease, endocrine disease)
- other signficant illnesses (e.g. malignancy, immunodeficiency syndromes, psychiatric illness)
- impossibility to measure outcomes (plannen relocation, language issues, short life expectancy)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-dec-2018
- planned closingdate1-dec-2020
- Target number of participants40
- InterventionsRandomization in a 1:1 to either:
- tofacitinib arm: induction therapy 10mg oral tablets twice daily during 8 weeks and maintenance therapy 5mg tablets twice daily until week 52
- infliximab arm: induction therapy with infliximab infusions 5mg/kg on week 0, 2 and 6 and maintenance therapy of infliximab infusions 5/mg/kg every 8 weeks

Additional interventions:
- vena punction for serum sample analyses
- home test for stool sampling
- questionnaires
(- preferably, endoscopy)
- Primary outcomeChanges in HDL- and LDL-cholesterol concentrations after tofacitinib and infliximab induction therapy of 8 weeks
- Secondary outcome- Changes in total cholesterol, triglycerides, apo-A1, apo-B, Lp(a) after induction therapy
- Changes in total cholesterol, HDL, LDL, triglycerides, apo-A1, apo-B, Lp(a) after maintenance therapy
- Correlation between lipid changes and inflammatory status
- Shifts in density of lipoproteins and their subfractions with alterations in their composition and functioning
- Effect of treatment on HDL2 and HDL3 composition and functioning (including anti-inflammatory function)
- Effect of treatment on cholesterol homeostasis (cholesterol absorption, synthesis, bile acid synthesis and oxysterol formation)
- Mechanisms underlying changes in lipoproteins focussing on cholesterol metabolism, inflammation, insulin resistance and bile acids
- Difference in change in lipid profile between tofacitinib and infliximab treatment
- Difference in treatment efficacy with regard to clinical, biochemical and endoscopic response
- Difference in safety profile measured by adverse events (AEs)
- TimepointsInfliximab: weeks 0, 5, 8, 21, 52
Tofacitinib: weeks 0, 5, 8, 21, 34, 47, 52
- Trial web site
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Education, Culture and Science
- Publications
- Brief summaryRecently tofacitinib is registered for the treatment of moderate to severe ulcerative colitis. In the tofactinib clinical development program (OCTAVE), mild elevations in serum lipid levels in a proportion of those receiving tofacitinib were described without further side effects. Mild alterations in the lipid profile are also observed in patients with inflammatory bowel disease (IBD) treated with infliximab (IFX). Although an overall increase in total cholesterol and low density lipoprotein cholesterol (LDL-C) is unwanted, an increase in high density lipoprotein cholesterol (HDL-C) as a result of treatment might protect against cardiovascular events. Moreover, these findings are consistent with the previously observed inverse relationship between active inflammation and serum lipid levels in chronic inflammatory disease including rheumatoid arthritis (RA) and psoriatic arthritis (PA). The mechanisms by which the inflammatory process can lead to these lipid changes are not fully understood.
- Main changes (audit trail)
- RECORD22-okt-2018 - 9-nov-2018

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